Pfizer Jobs

Associate Manager-Quality Investigation

Pfizer

Associate Manager-Quality Investigation

Posted Yesterday

Be an Early Applicant

Vizag, Vishākhapatnam, Andhra Pradesh, IND

In-Office

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Reviews and challenges microbiological deviations, OOS/OOT events, contamination investigations, environmental monitoring excursions, and sterility assurance investigations. Evaluates root cause analysis, data integrity, risk, CAPA effectiveness, regulatory compliance, and scientific rationale. Partners with cross-functional teams, coaches investigation owners, identifies systemic trends, and supports contamination control and continuous improvement in sterile pharmaceutical manufacturing.

Summary Generated by Built In

Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients.
Key Responsibility

Independently review and challenge microbiological deviation, OOS/OOT, contamination, environmental monitoring (EM) excursion, sterility assurance, and objectionable organism investigations to ensure scientific robustness and regulatory compliance.
Evaluate investigation strategy, data integrity, and adequacy of evidence to ensure conclusions are supported by facts and scientific rationale.
Drive effective root cause analysis utilizing structured investigation tools such as 5-Why, Fishbone Analysis, Fault Tree Analysis, and Human Error Reduction techniques.
Assess product, process, patient, and compliance risks and ensure appropriate risk mitigation measures are identified and implemented.
Review and challenge proposed CAPAs to ensure they address the true root cause and are capable of preventing recurrence.
Ensure investigations comply with cGMP requirements, internal quality standards, and regulatory expectations from FDA, EMA, MHRA, PIC/S, and WHO.
Partner with Microbiology, Manufacturing, Engineering, Technical Services, Validation, and Quality teams to strengthen investigation effectiveness and quality culture.
Coach investigation owners on scientific reasoning, critical thinking, technical writing, and investigation best practices.
Identify recurring trends, systemic gaps, and opportunities for continuous improvement within microbiological quality systems.
Support contamination control strategies and continuous improvement initiatives related to aseptic processing and sterility assurance.

Key Deliverables

Timely closure of microbiological investigations without compromising investigation quality.
Improved effectiveness and depth of root cause analysis.
Reduction in repeat deviations and recurring contamination-related events.
Enhanced quality and regulatory compliance of investigation reports.
Improved CAPA effectiveness and sustainability.
Strengthened contamination control and sterility assurance practices.
Increased capability of site personnel in performing scientifically sound investigations.
Improved inspection readiness and reduction in regulatory observations related to investigation quality.
Development of a robust knowledge base for microbiology-related quality events and lessons learned.

Education Qualification

B.Pharm, M.Pharm, M.Sc. Microbiology, Biotechnology, Pharmaceutical Sciences, or related discipline.
6+ years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, or investigation management.

Required Skills

Quality Assurance
Quality Management Systems (QMS)
Microbiological Investigations
Root Cause Analysis
Risk Management
Data Integrity
Regulatory Compliance (FDA, EMA, MHRA, PIC/S)
Technical Report Review and Approval

Transferable Skills to Develop

Critical Thinking and Scientific Decision Making
Investigative Interviewing Techniques
Risk-Based Assessment and Prioritization
Data Analysis and Trend Evaluation
Technical Writing and Report Critique
Influencing Without Authority
Problem Solving and Systems Thinking
Stakeholder Management
Effective Communication and Coaching

Key Investigator & Reviewer Competencies

Ability to distinguish symptoms from true root causes.
Ability to challenge assumptions and identify investigation gaps.
Strong analytical mindset with attention to detail.
Capability to assess investigation completeness and scientific soundness.
Ability to identify bias and ensure fact-based decision making.
Strong understanding of human performance and human error reduction concepts.
Effective questioning and interviewing skills to obtain factual information.
Capability to evaluate product quality impact and patient risk objectively.

Values/Behaviours to Develop
Excellence

Focus on what matters most.
Measure outcomes and drive continuous improvement.
Demonstrate scientific rigor in decision making.
Promote a right-first-time investigation culture.

Courage

Speak up and challenge unsupported conclusions.
Make quality-based decisions using facts and data.

Equity

Demonstrate objectivity, fairness, and consistency in investigation reviews.

Joy

Foster collaboration, knowledge sharing, and continuous learning.

Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

Bachelor’s or master’s degree in Pharmacy, Microbiology, Biotechnology, Pharmaceutical Sciences, or a related discipline
6+ years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, or investigation management
Quality Assurance experience
Quality Management Systems experience
Microbiological investigations experience
Root cause analysis experience
Risk management experience
Data integrity knowledge
Regulatory compliance knowledge, including FDA, EMA, MHRA, PIC/S, and WHO expectations
Technical report review and approval experience

What the Team is Saying

View all jobs at Pfizer

View Pfizer Profile

Report Job

Am I A Good Fit?

beta

Get Personalized Job Insights.

Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.